The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension,especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are: Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension? Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis. Participants will: During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week. Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
During their stay in the hospital, the patients were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily (a total of 3 months)training sessions and intensive supervision and management by the online community at least once a week. All patients' routines were monitored by telemetry and data, photographs and video recordings were collected by a specialized agency. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved.
During their stay in the hospital, participants of the control group received health propaganda and education (7 days ± 3 days 1 week/times). After discharge from the hospital, the control group followed their daily routine.
Fuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGchanges in 6MWD after 3 months
The participants will undergo 6-minute walk test (6WMT), and the 6-minute walk distance (6MWD) will be recoreded.
Time frame: 3th month after enrollment
changes in muscle mass after 3 months
Muscle mass will be measured by bioelectrical impedance analysis using the InBody S10 (Biospace, Seoul, Korea) or MC-780A (Tanita, Tokyo, Japan).
Time frame: 3th month after enrollment
peak VO2
The participants will undergo pulmonary function test.
Time frame: 3th month after enrollment
VO2peak%
The participants will undergo pulmonary function test.
Time frame: 3th month after enrollment
VE/VCO2 slope
The participants will undergo pulmonary function test.
Time frame: 3th month after enrollment
PET CO2
The participants will undergo pulmonary function test.
Time frame: 3th month after enrollment
Changes in muscle mass evaluated by CT
Muscle mass will be measured by chest computed tomography (CT) images.
Time frame: 3th month after enrollment
Changes in grip strength
Grip strength, a measure of muscle strength, was assessed using a grip dynamometer T.K.K. 5401 Grip-D (Takei Scientific Instruments Co, Ltd, Niigata, Japan). The patient was seated in a chair with the digital hand dynamometer placed at 90◦ elbow flexion and the upper arm resting on the torso. The patient held the dynamometer with maximum force for 3 s, resting and then alternating left and right twice. The average of the highest values on the left and right sides was taken.
Time frame: 3th month after enrollment
the time for 5 sit-to-stand test
The participants will undergo 5 sit-to-stand test (5STS), and the time for 5STS will be recorded.
Time frame: 3th month after enrollment
Quality of life measured by SF-36 after 3 months
The participants will undergo SF-36 questionnaire survey, and the score will be recorded.
Time frame: 3th month after enrollment
Quality of life measured by SF-36 after 6 months
The participants will undergo SF-36 questionnaire survey, and the score will be recorded.
Time frame: 6th month after enrollment
Quality of life measured by emPHasis-10 after 3 months
The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded.
Time frame: 3th month after enrollment
Quality of life measured by emPHasis-10 after 6 months
The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded.
Time frame: 6th month after enrollment
Changes in WHO Cardiac Function Classification
The participants will Classificated according to the WHO Cardiac Function Classification.
Time frame: 3th month after enrollment
Change in NT-proBNP
The participants will undergo examination for NT-proBNP in serum.
Time frame: 3th month after enrollment
Change in TAPSE by cardiac doppler ultrasound
The participants will undergo cardiac doppler ultrasound, and the tricuspid annular plane systolic excursion (TAPSE) will be recorded.
Time frame: 3th month after enrollment
Changes in hemodynamic indice after 6 months
The hemodynamic indice will be measured by right heart catheter and recorded.
Time frame: 6th month after enrollment
Changes in sleep quality score after 3 months
The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded.
Time frame: 3th month after enrollment
Changes in sleep quality score after 6 months
The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded.
Time frame: 6th month after enrollment
Changes in psychosocial score after 3 months
The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded.
Time frame: 3th month after enrollment
Changes in psychosocial score after 6 months
The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded.
Time frame: 6th month after enrollment
All-cause mortality in 3 months
All-cause mortality will be recorded.
Time frame: 3th month after enrollment
All-cause mortality in 6 months
All-cause mortality will be recorded.
Time frame: 6th month after enrollment
The occurrence rate of primary events in pulmonary hypertension in 3 months
The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment.
Time frame: 3th month after enrollment
The occurrence rate of primary events in pulmonary hypertension in 6 months
The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment.
Time frame: 6th month after enrollment
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